Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding

Mastitis Clinical Trial

Official title:

A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405158
• Other study ID #: 84839
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: November 30, 2006
• Start date: January 2002
• Est. completion date: March 2004

Study information

• Verified date: November 2006
• Source: Karlstad University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

The objective of the study was to test the hypothesis that acupuncture treatment hastens recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers with 210 cases of breast inflammation (commonly called "mastitis") during breastfeeding were randomly assigned to one of three treatment groups. There were two groups where acupuncture was used and one without acupuncture. The mothers symptoms were recorded at the onset of health care contact and daily until recovery. All care interventions given, including antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk sample to test for bacterial growth. It was found that acupuncture did not shorten the women's contacts with health care services but did improve their symptoms on contact days 3 and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New Zealand where up to 100% are given antibiotics. Seven women (3.3% of those in the study) developed a breast boil and this is a similar number to a study in Australia where many more were treated by antibiotics. This could mean that many women throughout the world are given antibiotics when in fact they may recover without them. This is an important finding in relation to the fight against antibiotic resistant bacteria.

Description:

Objectives: to further compare acupuncture treatment and care interventions for the relief of inflammatory symptoms of the breast during lactation and to investigate the relationship between bacteria in the breast milk and clinical signs and symptoms.

Design: randomised, non-blinded, controlled trial of acupuncture and care interventions.

Setting: a midwife-led breast-feeding clinic in Sweden.

Participants: 205 mothers with 210 cases of inflammatory symptoms of the breast during lactation agreed to participate. The mothers were randomly assigned to one of three treatment groups, two of which included acupuncture amongst the care interventions and one without acupuncture. All groups were given essential care. Protocols, which included scales for erythema, breast tension and pain, were maintained for each day of contact with the breast-feeding clinic. A Severity Index (SI) for each mother and each day was created by adding together the scores on the erythema, breast tension and pain scales. The range of the SI was 0 (least severe) to 19 (most severe).

Findings: There was no significant difference in numbers of mothers in the treatment groups with the lowest possible score for severity of symptoms on contact days 3, 4 or 5. There were no statistically significant differences between the treatment groups for number of contact days needed until the mother felt well enough to discontinue contact with the breast-feeding clinic or for number of mothers prescribed antibiotics. There were significant differences in the mean SI scores on contact days 3 and 4 between the non-acupuncture group and the two acupuncture groups. Mothers with less favourable outcomes (≥ 6 contact days, n = 61) were, at first contact with the midwife more often given advice on correction of the baby’s attachment to the breast. An obstetrician was called to examine 20 % of the mothers and antibiotic therapy was prescribed for 15 % of the study population. The presence of Group B streptococci in the breast milk was related to less favourable outcomes.

Key conclusions and implications for practice: If acupuncture treatment is acceptable to the mother, this, together with care interventions such as correction of breast-feeding position and babies’ attachment to the breast might be a more expedient and less invasive choice of treatment than the use of oxytocin nasal spray. Midwives, nurses or medical practitioners with specialist competence in breast feeding should be the primary care providers for mothers with inflammatory symptoms of the breast during lactation. The use of antibiotics for inflammatory symptoms of the breast should be closely monitored in order to help the global community reduce resistance development among bacterial pathogens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Lactating mothers with symptoms of breast inflammation

• Any mixture of increased breast tension, fever, breast erythema, lumps in the breast

Exclusion Criteria:

• Non-Swedish speaking

• Psychiatric illness

• Hemorrhagic disease

• Prosthetic heart valves

• Skin infections

• Hepatitis B

• HIV positive.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mastitis

Intervention

Procedure:
• Acupuncture treatment

• Administration of oxytocin nasal spray

• Improved breast milk removal

• Warmth applied to breasts

• Breast massage

Drug:
• Anti-pyretic medication, paracetamol

• cefadroxil

• penicillin

• flucloxacillin

Locations

Country	Name	City	State
Sweden	Dept Obstetrics & Gynecology, Helsingborg Hospital	Helsingborg	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Karlstad University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Kvist LJ, Hall-Lord ML, Rydhstroem H, Larsson BW. A randomised-controlled trial in Sweden of acupuncture and care interventions for the relief of inflammatory symptoms of the breast during lactation. Midwifery. 2007 Jun;23(2):184-95. Epub 2006 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women with lowest possible scores for symptom severity on days 3,4 and 5 in the three groups
Primary	Comparison of the three groups for mean scores for symptom severity on days 3,4 and 5
Primary	Comparison of the three treatment groups for number of contact days with health care services until recovery
Primary	Proportion of mothers in the three groups with less favourable outcomes (6 or more contact days to recovery)
Primary	Comparison of the three groups for proportions of women prescribed antibiotics
Primary	Comparison of the three groups for proportions of mothers who developed breast abscess
Primary	Proportions of women in the three groups who experienced residual symptoms within 6 weeks which required renewed health care contact
Primary	Comparison of the three groups for care interventions used
Secondary	Amounts of bacteria in the breast milk and correlated to erythema, increased breast tension and pain at first contact
Secondary	Type of bacteria in breast milk related to favourable outcomes (5 or less contact days) and less favorable outcomes (6 or more contact days)
Secondary	Differences in care interventions used in relation to favourable/less favourable outcomes
Secondary	Relationship between the occurrence of residual symptoms and the use of antibiotics

External Links

•   Karlstad University Webb page